NDC 41415-050 Publix Antibiotic Plus Pain Relief

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride Ointment Topical

  1. Labeler Index
  2. Publix Super Markets Inc
  3. NDC: 41415-050 Publix Antibiotic Plus Pain Relief

NDC Product Code 41415-050

NDC CODE: 41415-050

Proprietary Name: Publix Antibiotic Plus Pain Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • This product is used as active ingredients (each gram contains)purposebacitracin zinc 500 unitsfirst aid antibioticneomycin sulfate 3.5 mgfirst aid antibioticpolymyxin b sulfate 10,000 unitsfirst aid antibioticpramoxine hydrochloride 10 mgtopical analgesic

NDC Code Structure

NDC 41415-050-75

Package Description: 1 TUBE in 1 CARTON > 28.4 g in 1 TUBE

NDC Product Information

Publix Antibiotic Plus Pain Relief with NDC 41415-050 is a human over the counter drug product labeled by Publix Super Markets Inc. The generic name of Publix Antibiotic Plus Pain Relief is bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride. The product's dosage form is ointment and is administered via topical form.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Publix Antibiotic Plus Pain Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
  • PETROLATUM (UNII: 4T6H12BN9U)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacologic Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Publix Super Markets Inc
Labeler Code: 41415
FDA Application Number: part333B What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Start Marketing Date: 03-31-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Neomycin, Polymyxin, and Bacitracin Topical

Neomycin, Polymyxin, and Bacitracin Topical is pronounced as (nee oh mye' sin) (pol i mix' in) (bass i tray' sin)

Why is neomycin, polymyxin, and bacitracin topical medication prescribed?
Neomycin, polymyxin, and bacitracin combination is used to prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Neomycin, polymyxin, and b...
[Read More]
Pramoxine

Pramoxine is pronounced as (pra mox' een)
Why is pramoxine medication prescribed?
Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation...
[Read More]

* Please review the disclaimer below.

Publix Antibiotic Plus Pain Relief Product Label Images

Publix Antibiotic Plus Pain Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

DISTRIBUTED BY PUBLIXSUPER MARKETS, INC.3300 PUBLIX CORPORATEPARKWAYLAKELAND, FL 33811

Otc - Purpose

Active ingredients (each gram contains)PurposeBacitracin zinc 500 unitsFirst aid antibioticNeomycin sulfate 3.5 mgFirst aid antibioticPolymyxin B sulfate 10,000 unitsFirst aid antibioticPramoxine hydrochloride 10 mgTopical analgesic

Uses

  • First aid to help prevent infection and for the temporary relief of pain or discomfort inminor cutsscrapesburns

Warnings

For external use only

Otc - Do Not Use

  • Do not use in the eyesover large areas of the bodyif you are allergic to any of the ingredientslonger than 1 week

Otc - Ask Doctor

  • Ask a doctor before use on deep or puncture wounds, animal bites, or serious burns

Otc - Stop Use

  • Stop use and ask a doctor ifcondition gets worsecondition persists for more than 7 dayscondition clears up and occurs again within a few daysa rash or other allergic reaction develops

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 2 years of age and older:clean the affected area and dry thoroughlyapply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times dailymay be covered with a sterile bandageChildren under 2 years of age: consult a doctor

Other Information

  • To open: unscrew cap, pull tab to remove foil sealstore at room temperaturesee carton or tube crimp for lot number and expiration date

Inactive Ingredient

White petrolatum

* Please review the disclaimer below.